Psychiatric medications, science, marketing, psychiatry in general, and occasionally clinical psychology. Questioning the role of key opinion leaders and the use of "science" to promote commercial ends rather than the needs of people with mental health concerns.

Friday, September 21, 2007

Pharma Giles has a wonderful post about a fake antipsychotic and its dubious marketing which is similar to a real ad campaign for Geodon. The post on Pharma Giles is hilarious, and the FDA letter that slaps Pfizer for its false marketing of Geodon is worth a read as well. Geodon was featured in a medical journal ad that offended the sensibilities of the FDA. Here are some highlights...

Specifically, the journal ad fails to include the warnings for neuroleptic malignant syndrome, tardive dyskinesia, and hyperglycemia and diabetes mellitus. The journal ad does mention “movement disorders” and “low EPS,” and while we do not object to these claims, the presentations are insufficient to communicate the risk concepts associated with, and the seriousness of, tardive dyskinesia. Additionally, the professional journal ad fails to include important precautions, specifically, rash, orthostatic hypotension, and seizures. By omitting these risks, the journal ad misleadingly suggests that Geodon for Injection is safer than has been demonstrated.

The ad made a claim that:

Proven advantages over haloperidol IM―twice the improvement as measured on the BPRS”

This presentation is misleading because it implies that Geodon for Injection is more effective than haloperidol IM when this has not been demonstrated by substantial evidence or substantial clinical experience. The single study cited for this claim was an open-label study, which is not an appropriate study design to evaluate subjective endpoints, such as those measured by the Brief Psychiatric Rating Scale anchored version (BPRS), because of the potential for evaluator bias. In fact, FDA is not aware of any substantial evidence to support this claim.

3 comments:

Injectable Geodon is being used RIGHT NOW inside involuntary psych hospitals,being used as forced medication compliance practices, until a patient willingly swallows a pill. Geodon, unfortunately has moved into a medicaid-paid-system, and in the end, none of the patients I've met have access to your post to even wonder is being injected into their ass.--just something to think about--because the harm being done by false data/lies and scandal,ghost authorship, etc. is in the end harming people. They've got names and faces. I know one. My daughter.I have a new hatred of Geodon. Shocking, I know.

Very sad. It's funny that the FDA even bothers to level fines for false advertising. It does not even serve as a deterrent, but I suppose the FDA gets some positive PR out of looking like they are protecting the public health on occasion.

Let's be honest here and get back to reality. Derailing a medication isn't going to change the medical conditions we and our loved ones may have.If you read the results the FDA was penalizing them for non-disclosure of potential (but rare) side effects. NOT for advertising a drug which was not effective.There's a big difference. We all have grief over what life has tossed our way but don't deprive others of a chance to scrutinize the true merits and risks of opportunities for temporary relief from your own challenges. If you have accurate information or have issues where you have ruled out other causalities then by all means share them.But let's get away from generalities and unsupported attacks on drugs which have a resounding support of the medical field and can be life savers for those who cannot take other similar drugs due to weight gain, diabetes, and other risks.Find your choices, research them until you've exhausted the sources, and then make your own personal choice. Don't let anyone sway you on their word alone unless they have a lot of objective evidence to back it up. You or your loved is much too precious for that. God's speed I pray you find some answers which work for you!

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About Me

I'm an academic with a respectable amount of clinical experience and no drug industry funding. Given my lack of time, don't expect multiple daily updates. Certain things about clinical psychology, the drug industry, psychiatry, and academics drive me nuts, and you'll probably pick up on these pet peeves before long...